Clinical Trials Logo
  1. Home
  2. Breast Cancer
  3. NCT03377036
  4. Details
NCT03377036 Clinical Trial

Breast Cancer Screening: Digital Breast Tomosynthesis Versus Digital 2D Mammography

Breast Cancer Screening Clinical Trial

— TOSYMA  

Official title:
Prospective Randomized Comparison of Digital Breast Tomosynthesis Plus Synthesized Images Versus Standard Full-field Digital Mammography in Population-based Screening (TOSYMA)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03377036
Other study ID # UKM14_0016
Secondary ID HE1646/5-1 and H
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 5, 2018
Est. completion date March 31, 2025

Study information
Verified date March 2022
Source University Hospital Muenster
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a randomized, multicenter, multivendor, controlled, diagnostic superiority trial to compare digital breast tomosynthesis plus synthesized 2D mammograms (DBT+s2D) versus standard 2D full-field digital mammography (2D-FFDM) regarding the effectiveness as screening modality.

Description:

The primary objective of the study is to evaluate whether digital breast tomosynthesis plus synthesized 2D mammograms leads to a relevant increase in the detection rate of screening-detected invasive cancers compared to 2D full-field digital mammography in routine screening according to the European Guidelines. Furthermore, the incidence rate of interval cancers within a 24 months interval after screening will be compared between both study arms in order to investigate the potential for overdiagnosis. According to the pre-defined order of both primary endpoints and the primary objective of the study in the planning phase, the initial sample size calculation was based solely on the first primary endpoint (invasive breast cancer detection rate). Given the increasing national and international attention of interval cancers to assess the impact of potential overdiagnosis caused by tomosynthesis, we have planned a sample size increase from 80,000 to 120,000 study participants to achieve a reasonable statistical power for the evaluation of both primary endpoints. The revised sample size calculation was carried out without knowledge of the data from the currently recruiting TOSYMA study, i.e. all planning assumptions were based on external data that do not belong to the ongoing study.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 99689
Est. completion date March 31, 2025
Est. primary completion date March 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 50 Years to 69 Years
Eligibility Inclusion Criteria: - Women eligible to participate in the National Mammography Screening Program of Germany - Informed decision for mammography screening - Written informed consent - No prior participation in the TOSYMA trial Exclusion Criteria: - Breast cancer up to 5 years prior to study invitation - Previous mammography examination < 12 months, - Breast implants

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• DBT+s2D
Digital breast tomosynthesis plus synthesized 2D mammograms
• 2D-FFDM
2D full-field digital mammography

Locations
Country Name City State
Germany Screening-Einheit Aachen-Düren-Heinsberg; Mammographie-Einheit Aachen Aachen Nordrhein-Westfalen
Germany Referenz-Screening-Einheit Münster-Nord/Warendorf; Mammographie-Einheit Ahlen Ahlen Nordrhein-Westfalen
Germany Screening-Einheit Köln rechtsrheinisch, Leverkusen, Rhein.-Berg. Kreis, Oberbergischer Kreis; Mammographie-Einheit Bergisch Gladbach Bergisch Gladbach Nordrhein-Westfalen
Germany Screening-Einheit Bielefeld, Gütersloh; Mammographie-Einheit Bielefeld Bielefeld Nordrhein-Westfalen
Germany Screening-Einheit Münster-Süd; Mammographie-Einheit Coesfeld Coesfeld Nordrhein-Westfalen
Germany Screening-Einheit Duisburg; Mammographie-Einheit Duisburg Duisburg Nordrhein-Westfalen
Germany Screening-Einheit Gelsenkirchen, Kreis Recklinghausen, Bottrop; Mammographie-Einheit Gelsenkirchen Gelsenkirchen Nordrhein-Westfalen
Germany Screening-Einheit Hannover; Mammographie-Einheit Hannover Hannover Niedersachsen
Germany Screening-Einheit Minden-Lübbecke, Herford; Mammographie-Einheit Herford Herford Nordrhein-Westfalen
Germany Screening-Einheit Mönchengladbach, Krefeld, Viersen; Mammographie-Einheit Krefeld Krefeld Nordrhein-Westfalen
Germany Screening-Einheit Höxter, Paderborn, Soest; Mammographie-Einheit Lippstadt Lippstadt Nordrhein-Westfalen
Germany Screening-Einheit Niedersachsen Nordost; Mammographie-Einheit Lüneburg Lüneburg Niedersachsen
Germany Referenz-Screeening-Einheit Münster-Nord/Warendorf; Mammographie-Einheit Münster-Nord Münster Nordrhein-Westfalen
Germany Screening-Einheit Münster-Süd; Mammographie-Einheit Münster Münster Nordrhein-Westfalen
Germany Screening-Einheit Höxter, Paderborn, Soest; Mammographie-Einheit Paderborn Paderborn Nordrhein-Westfalen
Germany Screening-Einheit Märkischer Kreis, Hamm, Unna; Mammographie-Einheit Schwerte Schwerte Nordrhein-Westfalen
Germany Screening-Einheit Raum Bergisch Land/Kreis Mettmann; Mammographie-Einheit Solingen-Mitte Solingen Nordrhein-Westfalen
Germany Screening-Einheit Niedersachsen Nord; Mammographie-Einheit Stade Stade Niedersachsen
Germany Screening-Einheit Niedersachsen Mitte; Mammographie-Einheit Vechta Vechta Niedersachsen
Germany Screening-Einheit Niedersachsen Nordwest; Mammographie-Einheit Wilhelmshaven Wilhelmshaven Niedersachsen
Germany Screening-Einheit Raum Bergisch Land/Kreis Mettmann; Mammographie-Einheit Wuppertal-Elberfeld Wuppertal Nordrhein-Westfalen

Sponsors (2)
Lead Sponsor Collaborator
University Hospital Muenster German Research Foundation

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Weigel S, Gerss J, Hense HW, Krischke M, Sommer A, Czwoydzinski J, Lenzen H, Kerschke L, Spieker K, Dickmaenken S, Baier S, Urban M, Hecht G, Heidinger O, Kieschke J, Heindel W. Digital breast tomosynthesis plus synthesised images versus standard full-field digital mammography in population-based screening (TOSYMA): protocol of a randomised controlled trial. BMJ Open. 2018 May 14;8(5):e020475. doi: 10.1136/bmjopen-2017-020475. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Detection rate of invasive breast cancers Number of women with screening-detected invasive breast cancer divided by the number of all women screened. A screening-detected breast cancer is classified as invasive carcinoma if the pT category (pathological tumor size) of the TNM classification falls into one of the following categories: pT1mic, pT1a, pT1b, pT1c, pT1, pT2, pT3, pT4a, pT4b, pT4c, pT4d, pT4, pTX (for evaluation purpose pTX defines histologically approved invasive breast cancer with missing tumor diameter) or the final pathological categorization has been done after neoadjuvant therapy (ypT), implying an invasive cancer prior to therapy. Routine screening visit
Primary Cumulative 24 months incidence of interval cancers The 24 months incidence of interval cancers is defined as the number of women that develop a ductal carcinoma in situ or an invasive breast cancer in the 24 months interval after a negative screening examination divided by the number of all women with a negative screening result. 24 months after routine screening visit
Secondary Detection rate of ductal carcinoma in situ (DCIS) Number of women with screening-detected ductal carcinoma in situ (if the pT category of the TNM classification falls into the category pTis) divided by the number of all women screened. Routine screening visit
Secondary Detection rate of tumor category pT1 Number of women with screening-detected invasive breast cancers of the category pT1 divided by the number of all women screened. A screening-detected breast cancer is classified as breast cancer of tumor category pT1 if tumor size is = 20 mm in greatest dimension and the respective pT subcategory of the pTNM classification is one of the following: pT1mic, pT1a, pT1b, pT1c, pT1. Routine screening visit
Secondary Recall rate for further assessment Number of women with recalls for further assessment divided by the number of all women screened. Routine Screening Visit
Secondary Positive predictive value of recall for further assessment (PPV1) Number of women with screening-detected malignancies (ductal carcinoma in situ or invasive breast cancer) divided by the number of women with recalls for further assessment. Routine screening visit
Secondary Cumulative 12 months incidence of interval cancers The 12 months incidence of interval cancers is defined as the number of women that develop a ductal carcinoma in situ or an invasive breast cancer in the 12 months interval after a negative screening examination divided by the number of all women with a negative screening result. 12 months after routine screening visit
See also
  Status Clinical Trial Phase
Completed NCT04601272 - Evaluating the Shared Decision Making Process Scale in Cancer Screening Decisions
Completed NCT03979729 - Breast Cancer Screening for Underserved Women: Comparing Outcomes and Lowering Recall Rates With 3D- vs. 2D-mammography
Completed NCT02198690 - Trial of a Mammography Decision Aid for Women Aged 75 and Older N/A
Completed NCT01885741 - Study to Demonstrate the Preliminary Safety and Effectiveness of IPBS in Performing MRI-Guided Targeting and Intervention of Breast Tissue in Female Patients Indicated for MRI-Guided Breast Biopsy N/A
Completed NCT01267110 - Engaging Diverse Underserved Communities to Bridge the Mammography Divide N/A
Completed NCT00287040 - Breast Cancer Screening Via Computer V. Phone Phase 3
Recruiting NCT05268224 - A Tear-based, Lab-developed Test for Breast Cancer for Women With Dense Breast Tissue
Recruiting NCT06098118 - Adapting a Mammography Decision Aid to Support Women Living in a Community Contaminated by PFAS N/A
Completed NCT05821023 - Messaging Strategies to Reduce Breast Cancer Over-screening in Older Women N/A
Recruiting NCT05841355 - Empowering Latinas to Obtain Guideline Concordant Screenings N/A
Recruiting NCT05960188 - Project 1: Self-Triage by 2D Full-field Digital Mammography or Synthetic Images N/A
Recruiting NCT04429269 - A Comparative Study of Mammography and Ultrasound for Breast Cancer Screening and Early Diagnosis
Completed NCT05756725 - Improving Cancer Screening and Follow-up in Community Health Centers N/A
Enrolling by invitation NCT06059300 - Digital Breast Tomosynthesis for the Dutch National Breast Cancer Screening Program N/A
Completed NCT03046004 - Effect of Information About the Benefits and Harms of Mammography on Women's Decision Making N/A
Completed NCT03517813 - CESM ABMR Breast Cancer Screening Trial
Completed NCT02273206 - Collaborative Care to Reduce Depression and Increase Cancer Screening Among Low-Income Urban Women N/A
Completed NCT00224224 - A Comparison of Primary Care and Traditional Internal Medicine Residents N/A
Recruiting NCT04102722 - Safety and Performance of the Multi-Modal UltraSound Tomography (MUST) Device in Breast Cancer Screening N/A
Completed NCT04259866 - FALSE POSITIVE FINDINGS IN BREAST CANCER TOMOSYNTHESIS

External Links